Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007388124

FEI Number

3007388124

Entity Name

HAEMOBAND SURGICAL LTD

City/State/Country

Belfast Northern Ireland, GB

Establishment Address

The Mount Conference Centre, 2 Woodstock Link, Belfast Northern Ireland BT6 8DD, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Haemoband Surgical Ltd (Owner Number: 10031121)

Owner / Operator Contact Address

The Mount Conference Centre, 2 Woodstock Link, Belfast, GB-ANN BT6 8DD, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250645

PMA Number

N/A

All Registered Proprietary Names

SleeveLUX 24 Anoscope/Proctoscope SleeveLUX 16 Anoscope/Proctoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2025-11-20
GCP	Endoscope, Ac-Powered And Accessories	Gastroenterology, Urology	Class 2	876.1500	2025-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

Haemoband Surgical Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007388124. Last updated year: 2026. Please use registration number 3007388124 when referencing this establishment in official correspondence.